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6 January 2025 Patrick Branch, head of Japan and APAC business development at Nxera Pharma,
Japan’s most innovative and nimble biopharma company, provides a summary of the year in the important eastern market.
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Metsera today announced positive data from a 12-week Phase IIa clinical trial of MET-097i, its potential once-monthly, ultra-long acting, subcutaneously injectable, fully-biased, GLP-1 receptor agonist (RA). 7 January 2025
Pharmaceutical
Central nervous system (CNS) specialist Neuraxpharm Group has acquired Provigil (modafinil) and Nuvigil (armodafinil), both of which are indicated for the treatment of excessive daytime sleepiness (EDS) in adults with narcolepsy. 7 January 2025
Pharmaceutical
Japan-based FUSO Pharmaceutical Industries and Australia’s Dimerix Limited have entered into an exclusive development and license agreement for the development and commercialization of Dimerix’ Phase III drug candidate DMX-200 for the treatment of focal segmental glomerulosclerosis (FSGS) kidney disease in Japan. 7 January 2025
Pharmaceutical
The heart failure market is projected to grow at a compound annual growth rate of 9.6% over the next decade, increasing from $13.5 billion in 2022 to $33.7 billion in 2032 across seven major markets, according to a report from analytics firm GlobalData. 7 January 2025
Pharmaceutical
A late-stage trial failure has dented Denali Therapeutics stock, with an announcement Monday revealing the HEALEY ALS study missed all endpoints. 7 January 2025
Pharmaceutical
Unquestionably, US drugmaker Vertex Pharmaceuticals is the dominant drug developer in the cystic fibrosis (CF) space.
How has the company achieved this — on the R&D and patient access side — and what is the company doing to help the remaining patients? Vertex’s Andrew Wilfin, Senior Country Medical Director, UK and Ireland, took part in a Q&A with The Pharma Letter to reveal all. 7 January 2025
Pharmaceutical
The US Food and Drug Administration (FDA) issued a draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality. 7 January 2025
Pharmaceutical
Sentynl Therapeutics, wholly owned by Zydus Lifesciences, has announced that the US Food and Drug Administration has accepted its New Drug Application for CUTX-101, a potential first treatment for Menkes disease. The application has been granted priority review, with a target action date set for June 30, 2025. 7 January 2025
Pharmaceutical
rug Administration (FDA) approved an update to the US Prescribing Information (USPI) for Pyrukynd (mitapivat) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency, Agios Pharmaceutical revealed in a Security and Exchange Commission (SEC) notice. 7 January 2025
Pharmaceutical
A team of Chinese researchers has identified a promising candidate for glaucoma treatment using artificial intelligence tools. 6 January 2025
Pharmaceutical
Patrick Branch, head of Japan and APAC business development at Nxera Pharma,
Japan’s most innovative and nimble biopharma company, provides a summary of the year in the important eastern market. 6 January 2025
Pharmaceutical
Immedica Pharma, a Swedish company specializing in rare diseases, has announced its acquisition of Marinus Pharmaceuticals in a deal valued at $151 million. The agreement, finalized through a cash tender offer, marks a significant expansion of Immedica’s presence in the US market. 6 January 2025
Pharmaceutical
Anglo-Swedish drugmaker AstraZeneca has announced that new, positive, long-term results from the pivotal ALPHA Phase III trial have appeared in the journal Blood, which is published by the American Society of Hematology. 6 January 2025
Pharmaceutical
Alon Natanson, a business leader and alumnus of the Hebrew University of Jerusalem, has been appointed chief executive officer (CEO) of Yissum, the Israeli Hebrew University Tech Transfer company. 6 January 2025
Pharmaceutical
Japanese drugmaker Otsuka Pharmaceutical has announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for the hereditary angioedema(HAE) drug candidate donidalorsen. 6 January 2025
Pharmaceutical
Switzerland’s Santhera Pharmaceuticals has entered an exclusive deal with Clinigen Group to manage the supply and distribution of Agamree (vamorolone) in regions where the drug is not yet commercially available. 6 January 2025
Pharmaceutical
Full mergers and acquisitions in the pharmaceutical and biotechnology in 2024 fluctuated throughout the year with hardly any in some months and a significant number in other. But one thing was clear – buyers were shying away from big bets on commercially ready medicines in favor of earlier stage drug developers. 3 January 2025
Pharmaceutical
Regeneron Pharmaceuticals has acquired UK-based biotech Oxular, enhancing its gene therapy development program with the firm’s specialized ocular delivery tech. 3 January 2025
Pharmaceutical
One of the most promising areas of medical innovation in the next five years is immuno-oncology (I-O)/cancer therapeutics represent, fundamentally transforming how cancer is treated. 3 January 2025
Pharmaceutical
Massachusetts, USA-based based brain disease biotech Neumora Therapeutics shares tumbled 81.4% to 1.97 after it revealed that its experimental depression treatment failed in the first of three studies planned by the biotech company. 3 January 2025
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Pharmaceutical
UK pharma major AstraZeneca today released results from the FLAURA2 Phase III trial that showed its Tagrisso (osimertinib) with the addition of chemotherapy provided a clinically-meaningful and consistent benefit in subsequent outcomes after disease progression in patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). 21 March 2024
Pharmaceutical
Seelos Therapeutics, a company working on therapies for amyotrophic lateral sclerosis (ALS) and other central nervous system disorders (CNS) has been struck by a trial failure. 21 March 2024
Pharmaceutical
Since Swiss pharma giant Roche’s Zelboraf (vemurafenib) gained US Food and drug Administration (FDA) approval in 2011, significant strides have been made in BRAF-targeted cancer therapies, underscoring the significance of combating BRAF mutations in melanoma. 21 March 2024
Pharmaceutical
UK and US-listed drugmaker PureTech Health has announced plans to return $100 million to its shareholders by way of a tender offer. 20 March 2024
Pharmaceutical
A statement from the Centers for Disease Control and Prevention (CDC) in the USA raises concerns about the spread of measles, a public health issue which has affected multiple countries in recent years. 20 March 2024
Pharmaceutical
Italfarmaco has announced that results from its pivotal Phase III EPIDYS trial with givinostat in ambulant boys aged six years and older with Duchenne muscular dystrophy (DMD) have been published in The Lancet Neurology. 20 March 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Tryvio (aprocitentan) for the treatment of hypertension. 20 March 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has granted accelerated approved the supplemental new drug application (sNDA) for Iclusig (ponatinib). 20 March 2024
Pharmaceutical
Positive results from French eye drug company Nicox have been published in the American Journal of Ophthalmology. 20 March 2024
Pharmaceutical
Madrigal Pharmaceuticals saw its shares close down 6.2% at $265.68 yesterday, after it announced the pricing of its underwritten public offering of 750,000 shares of its common stock. 20 March 2024
Pharmaceutical
Since the early 1980s, the Sultanate of Oman has been one of the first countries in the MENA region to establish “a state reserve stock” of essential medicines and medical supplies to deal with emergency situations, mitigate the effects of epidemics and disasters, and provide the necessary medical and emergency care at the proper time. 19 March 2024
Pharmaceutical
Even as India's 'vaccine diplomacy' initiative, supplying life-saving doses to low- and middle-income countries, embodies a larger cooperative mission for global health security, the humanitarian effort stands in stark contrast to the reality of India's own domestic vaccine market, dominated by multinational corporations (MNCs). 19 March 2024
Pharmaceutical
Crinetics Pharmaceuticals, a biopharma focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, was trading 14% higher by lunchtime Tuesday. 19 March 2024
Pharmaceutical
San Diego, USA-headquartered Conduit Pharmaceuticals, a disease agnostic life science company, today announced the appointment of Dr Joanne Holland as chief scientific officer (CSO). 19 March 2024
Pharmaceutical
Shanghai-based KeChow Pharma has secured approval in its home country for tunlametinib, a MEK blocker which was discovered and developed by the firm in-house. 19 March 2024
Pharmaceutical
German pharma major Bayer has announced positive top-line results from the Phase III OASIS 3 trial, adding to the successes of OASIS 1 and 2 earlier this year. 19 March 2024
Pharmaceutical
Shares of Canada-headquartered Fusion Pharmaceuticals were up more than 95% at $20.80 in pre-market activity, on the news of a takeover bid from UK pharma major AstraZeneca. 19 March 2024
Pharmaceutical
US radiopharmaceuticals-focussed company Lantheus Holdings has announced the promotion of Amanda Morgan to chief commercial officer (CCO) and her elevation to be a member of the company’s executive team, effective March 25, 2024. 19 March 2024
Pharmaceutical
Parexel, one of the world’s largest clinical research organizations (CROs), has announced a change at the top. 18 March 2024
Pharmaceutical
Mitsubishi Tanabe Pharma America has announced the publication of results in The Lancet Neurology from the pivotal, Phase III BouNDless trial. 18 March 2024
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